Updated 12/7/07 High Intensity Focused Ultrasound Sonablate ® HIFU A Non Invasive Way to Treat Prostate Cancer

Updated 12/7/07 HIFU with the Sonablate ® 500 What is HIFU? What is Sonablate ® HIFU? How does it work? History of HIFU Who Qualifies for HIFU? The HIFU Procedure Recovery & Follow Up Does HIFU work? Where is it available? How can I get more information?

Updated 12/7/07 What is HIFU? HIFU stands for High Intensity Focused Ultrasound Non-Invasive therapy that focuses sound waves to create heat Similar to light traveling through a magnifying glass to create heat Raises the temperature of the target tissue to almost 195 degrees Fahrenheit (90 degrees Celsius) Destroys the targeted tissues where sound waves cross 2000 W/cm 2 TransducerFocal Point

Updated 12/7/07 HIFU with the Sonablate ® 500 The Sonablate ® 500 is a medical device that uses HIFU to thermally ablate the prostate.

Updated 12/7/07 Brief History of HIFU HIFU research began in the 1950s in Indianapolis, IN. Over the years HIFU has evolved to the applications we have today which include treating various types of cancer and diseases. In 2004, the first International HIFU Centers opened in the Americas.

Updated 12/7/07 Status of HIFU in the US The Sonablate ® 500 is being studied in clinical trials for use in the treatment of prostate cancer in the United States and is not approved for use by the U.S. Food and Drug Administration. HIFU with the Sonablate ® 500 is authorized for use for the treatment of prostate cancer in Canada, Argentina and the Dominican Republic. It is also available in the Bahamas and Mexico.

Updated 12/7/07 Sonablate ® HIFU Today Over 100 International HIFU Centers in North & South America, Europe, Asia, and other countries where the device is approved Over 3,500 prostate cancer patients treated with the Sonablate ® 500 Over 6,000 patients treated with prostate disease (BPH and Cancer) Over 180 credentialed Sonablate ® users worldwide

Updated 12/7/07 Who Qualifies for HIFU? Ideal HIFU candidate: Localized prostate cancer PSA < 10 Gleason < 7 Prostate Volume 50 cc or less Patients who don’t fit this criteria may still qualify; discuss case with physician for final qualification

Updated 12/7/07 Who else Qualifies for HIFU? HIFU can also treat recurrent prostate cancer. This includes: Radiation failures Cryotherapy failures Surgical failures Brachytherapy failures (seeds) HIFU failures Benign prostatic hyperplasia (BPH)

Updated 12/7/07 The Sonablate ® HIFU Procedure 1-4 hour outpatient procedure, depending on size of prostate Spinal/epidural anesthesia with light sedative Therapy is delivered through a transrectal probe after patient is numbed from the waist down 1-2 hour recovery at HIFU treatment facility After procedure, most patients resume normal lifestyle within a few days In most cases, HIFU is a one time procedure. It is non-surgical, radiation free and has minimal blood loss.

Updated 12/7/07 Recovery & Follow Up Patients have a catheter that is removed days after HIFU. Office visit with doctor required for removal. Check PSA at 3, 6, 9 and 12 months then yearly thereafter.

Updated 12/7/07 Side Effects & Complications HIFU results from a study done in Japan show low rates of both –Impotence (<20%) –Incontinence (<0.6%) Minimal Complications –Discomfort associated with catheter –Tissue passing –Most are temporary and mild

Updated 12/7/07 MRI Pre and Post HIFU MRI Image of prostate Pre-HIFU MRI Image of prostate 2 weeks Post-HIFU

Updated 12/7/07 USHIFU Results & Data Physicians have treated more than 700 patients in Mexico, the Dominican Republic and Canada. According to a Japanese study, the disease free rate after 6 years is 97% for low risk patients (PSA < 10; Gleason < 6) Another small study from the UK showed that 92% of men had Nadir PSA of 0.2 ng/ml or lower after 3 months.

Updated 12/7/07 Results and Data # of SB Treatments worldwide # of SB Centers in world # of SB500 Users# of HIFU cases in North & South America Over 6,000Nearly 100Nearly 200Over 700 KEY FINDINGLength of Follow-Up PercentagePhysicianPresentation/Study Negative Biopsy Rate 1 year91%Sumitomo, Hayakawa, Nagakura One Year outcomes following HIFU Japan Endourology & ESWL Conference 2005 Biochemical Disease- Free Rate 6 years97% (low risk group: pre-HIFU PSA <10) Uchida, Shoi,NagataHIFU for Localized Prostate Cancer 6 year Experience Japan Endourology & ESWL Conference 2004 Nadir PSA after HIFU3 months92% (PSA of 0.2ng/ml or lower) Emberton, illing, Dawkins, Ogden British Prostate Group- Autumn Meeting 2005 Efficacy

Updated 12/7/07 Now that we know what Sonablate ® HIFU is… If you are interested in HIFU, you will need to know the following: PSA Gleason Prostate Volume (very important) Other therapies/treatments and any relevant medical history

Updated 12/7/07 Where is HIFU Available now? International HIFU Centers –Canada –Mexico –The Bahamas –Dominican Republic FDA approved Phase III Clinical Trial –All trial sites are currently full –Trial is not accepting additional subject applicants –Additional trial sites may open in the future

Updated 12/7/07 Where is HIFU Available now? International HIFU Centers Toronto, Ontario, Canada Niagara Falls, Ontario, Canada Puerto Vallarta, Mexico Cancun, Mexico Nassau, Bahamas Santo Domingo, Dominican Republic Information about individual centers is available per request: Center locations and facility details Hotel and travel information Local attractions at each location

Updated 12/7/07 Where can I get more information? Online: –Read patient testimonials, watch videos and more Call USHIFU Office to speak with a HIFU representative: Patient Booklet and DVD Speak with men who have already had HIFU

Updated 12/7/07 HIFU featured in Men’s Vogue

Updated 12/7/07 -Thank You- Questions?